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Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer

Primary Purpose

Pancreatic Cancer

Status

Terminated

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

gemcitabine hydrochloride

intensity-modulated radiation therapy

About this trial

This is an interventional treatment trial for Pancreatic Cancer focused on measuring adenocarcinoma of the pancreas, stage III pancreatic cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

DISEASE CHARACTERISTICS:

Pathologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas, ampulla of Vater, or distal bile duct
- Locally advanced disease
- Medically inoperable, unresectable, or borderline resectable disease
  - No previously resected disease (i.e., status post-pancreaticoduodenotomy)
No non-adenocarcinoma, adenosquamous carcinoma, islet cell carcinoma, cyst adenoma, cystadenocarcinoma, carcinoid tumor, or duodenal carcinoma
No lesions in the tail of the pancreas and/or splenic artery/vein involvement/encasement
No recurrent or metastatic (M1) disease

PATIENT CHARACTERISTICS:

Karnofsky performance status 60-100%
WBC > 3,000/μL
Platelet count > 100,000/μL
Bilirubin ≤ 2 mg/dL
SGOT < 5 times upper limit of normal (ULN)
Creatinine < 1.5 times ULN
Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
Adequate oral nutrition (e.g., ≥ 1,500 calories/day, stable weight for ≥ 2 weeks, and ≤ 5% weight loss)
No active malignancy within the past 3 years, except cervical carcinoma in situ or nonmelanoma skin cancer that has been removed
No severe, active comorbidity, including any of the following:
- Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months
- Transmural myocardial infarction within the past 6 months
- Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration
- Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within the past month or precluding study therapy at the time of study registration
- Active hepatitis, decompensated cirrhosis, or clinically significant liver failure
- Other severe comorbid condition, as determined by the principal investigator

PRIOR CONCURRENT THERAPY:

See Disease Characteristics
No prior chemotherapy
No prior radiotherapy to any upper abdominal site
No concurrent prophylactic colony-stimulating factors during radiotherapy
No concurrent warfarin
No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, surgery for cancer, or experimental therapy

Sites / Locations

Rutgers Cancer Institute of New Jersey

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Radiotherapy plus gemcitabine

Arm Description

Drug: gemcitabine hydrochloride Radiation: intensity-modulated radiation therapy

Outcomes

Primary Outcome Measures

Maximum tolerated dose of intensity-modulated radiotherapy (Phase I)

Overall survival (Phase II)

Disease-free survival (Phase II)

Secondary Outcome Measures

Full Information

NCT ID

NCT00878657

First Posted

April 8, 2009

Last Updated

May 1, 2014

Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

1. Study Identification

Unique Protocol Identification Number

NCT00878657

Brief Title

Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer

Official Title

Phase I/II Radiotherapy Dose Escalation Study in Locally Advanced Pancreatic Cancer, Using a Simultaneous Intensity Modulated Boost With Concurrent Gemcitabine

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Terminated

Why Stopped

Slow accrual

Study Start Date

April 2009 (undefined)

Primary Completion Date

October 2012 (Actual)

Study Completion Date

October 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Rutgers, The State University of New Jersey

Collaborators

National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

RATIONALE: Specialized radiation therapy that delivers a high dose of radiation directly to the tumor may kill more tumor cells and cause less damage to normal tissue. Drugs used in chemotherapy, such as gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving intensity-modulated radiation therapy together with gemcitabine may kill more tumor cells. PURPOSE: This phase I/II trial is studying the side effects and best dose of intensity-modulated radiation therapy and to see how well it works when given together with gemcitabine in treating patients with locally advanced pancreatic cancer.

Detailed Description

The study was terminated early due to slow accrual and only the phase I portion of hte study was opened. The phase of the study has been revised to only a phase I study. OBJECTIVES: To determine the maximum tolerated dose (MTD) of intensity-modulated radiotherapy delivered to the gross tumor volume when administered with gemcitabine hydrochloride in patients with locally advanced pancreatic carcinoma. (Phase I) To define the dose-limiting toxicities of this regimen in these patients. (Phase I) To determine the local control in patients treated at the MTD (determined in phase I). (Phase II) To compare the disease-free survival and time to progression in these patients with that of historical controls. (Phase II) OUTLINE: This is a multicenter phase I, dose-escalation study of intensity-modulated radiotherapy, followed by a phase II study. Induction chemotherapy: Patients receive gemcitabine hydrochloride IV on days 1, 8, and 15. Treatment repeats every 28 days for 2 courses in the absence of disease progression or unacceptable toxicity. Patients then undergo CT scan. Patients with no evidence of metastatic disease proceed to chemoradiotherapy. Chemoradiotherapy: Beginning 1-2 weeks after completion of induction chemotherapy, patients undergo intensity-modulated radiotherapy once daily 5 days a week and gemcitabine hydrochloride IV over 30 minutes once weekly for 5 weeks in the absence of disease progression or unacceptable toxicity. Patients whose disease remains unresectable proceed to adjuvant chemotherapy. Adjuvant chemotherapy: Beginning 4-6 weeks after completion of chemoradiotherapy, patients receive gemcitabine hydrochloride as in induction chemotherapy. After completion of study treatment, patients are followed every 3 months for 1 year, every 6 months for 2 years, and then annually thereafter.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Pancreatic Cancer

Keywords

adenocarcinoma of the pancreas, stage III pancreatic cancer

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

8 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Radiotherapy plus gemcitabine

Arm Type

Experimental

Arm Description

Drug: gemcitabine hydrochloride Radiation: intensity-modulated radiation therapy

Intervention Type

Drug

Intervention Name(s)

gemcitabine hydrochloride

Intervention Description

Pre-Chemoradiation (Induction) Chemotherapy Gemcitabine will be given weekly for seven doses at a dose of 1000 mg/m2/wk (Days 1, 8, 15, 22, 29, 36, 43) unless toxicity develops. Chemoradiation gemcitabine will be given 400 mg/m2, infused over 30 minutes, within 120 minutes before radiotherapy. Post-chemoradiation chemotherapy, patients will receive two cycles of gemcitabine. A cycle will be defined as three weeks of gemcitabine at 1000 mg/m2/d, once weekly, followed by a one-week rest.

Intervention Type

Radiation

Intervention Name(s)

intensity-modulated radiation therapy

Intervention Description

Dose escalation levels (cohorts) for this study: Dose Level 1: GTV plus drainage areas 45 Gy, Boost GTV 50.4 Gy Dose Level 2: GTV plus drainage areas 45 Gy, Boost GTV 54.0 Gy Dose Level 3: GTV plus drainage areas 45 Gy, Boost GTV 59.4 Gy Dose Level 4: GTV plus drainage areas 45 Gy, Boost GTV 64.8 Gy Dose Level 5: GTV plus drainage areas 45 Gy, Boost GTV 70.2 Gy

Primary Outcome Measure Information:

Title

Maximum tolerated dose of intensity-modulated radiotherapy (Phase I)

Time Frame

4 years

Title

Overall survival (Phase II)

Time Frame

4 years

Title

Disease-free survival (Phase II)

Time Frame

4 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

DISEASE CHARACTERISTICS: Pathologically confirmed adenocarcinoma or poorly differentiated carcinoma of the pancreas, ampulla of Vater, or distal bile duct Locally advanced disease Medically inoperable, unresectable, or borderline resectable disease No previously resected disease (i.e., status post-pancreaticoduodenotomy) No non-adenocarcinoma, adenosquamous carcinoma, islet cell carcinoma, cyst adenoma, cystadenocarcinoma, carcinoid tumor, or duodenal carcinoma No lesions in the tail of the pancreas and/or splenic artery/vein involvement/encasement No recurrent or metastatic (M1) disease PATIENT CHARACTERISTICS: Karnofsky performance status 60-100% WBC > 3,000/μL Platelet count > 100,000/μL Bilirubin ≤ 2 mg/dL SGOT < 5 times upper limit of normal (ULN) Creatinine < 1.5 times ULN Not pregnant or nursing Negative pregnancy test Fertile patients must use effective contraception Adequate oral nutrition (e.g., ≥ 1,500 calories/day, stable weight for ≥ 2 weeks, and ≤ 5% weight loss) No active malignancy within the past 3 years, except cervical carcinoma in situ or nonmelanoma skin cancer that has been removed No severe, active comorbidity, including any of the following: Unstable angina and/or congestive heart failure requiring hospitalization within the past 6 months Transmural myocardial infarction within the past 6 months Acute bacterial or fungal infection requiring IV antibiotics at the time of study registration Chronic obstructive pulmonary disease exacerbation or other respiratory illness requiring hospitalization within the past month or precluding study therapy at the time of study registration Active hepatitis, decompensated cirrhosis, or clinically significant liver failure Other severe comorbid condition, as determined by the principal investigator PRIOR CONCURRENT THERAPY: See Disease Characteristics No prior chemotherapy No prior radiotherapy to any upper abdominal site No concurrent prophylactic colony-stimulating factors during radiotherapy No concurrent warfarin No other concurrent chemotherapy, immunotherapy, hormonal cancer therapy, radiotherapy, surgery for cancer, or experimental therapy

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Salma Jabbour, MD

Organizational Affiliation

Rutgers Cancer Institute of New Jersey

Official's Role

Principal Investigator

Facility Information:

Facility Name

Rutgers Cancer Institute of New Jersey

City

New Brunswick

State/Province

New Jersey

ZIP/Postal Code

08903

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Intensity-Modulated Radiation Therapy and Gemcitabine in Treating Patients With Locally Advanced Pancreatic Cancer

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